ECTRIMS: Early Glatiramer Cuts MS Conversion Rate

Action Points

Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

Explain that the open-label continuation of the PreCISe study continues to show an advantage in MS for early intervention with Copaxone.

GOTHENBURG, Sweden -- Early treatment with glatiramer (Copaxone) proved superior to later treatment in reducing conversion to multiple sclerosis in patients with a clinically isolated syndrome, researchers said here.

Early treatment reduced the risk of conversion to definite MS by 41% compared with rates in those beginning treatment approximately two years later (P=0.0005), according to Giancarlo Comi, MD, of the Scientific Institute H.S. Raffaele in Milan, Italy.

"After five years, there is still a quite significant relative advantage for early treatment, in terms of time to conversion," Comi, lead investigator of the preplanned, two-year, open-label continuation of the double-blind PreCISe study told attendees at the European Committee for Treatment and Research in Multiple Sclerosis meeting.

The double-blind portion of PreCISe, originally planned as a three-year trial, was stopped after 2.3 years when it was clear the drug was effective for this purpose.

Patients were then offered the opportunity to receive active treatment in an open-label phase; 409 (85%) entered the open-label phase, and 289 completed it. At the end of the trial there were roughly equal numbers of patients who started the trial on active treatment and those who started on placebo.

Patients on active treatment from the start of the initial trial ( the "early treatment" group) were compared with those receiving placebo ("delayed treatment") for their conversion to CDMS and other parameters.

Besides the delayed conversion results, most other outcomes also favored early treatment. The number of new lesions, adjusted for total treatment time, was less, as was the annualized rate of T2 lesions. The absolute change in T2 volume was 50% less for early treatment. Brain atrophy was also less for those on early treatment.

There was no difference in the rate of disability progression during the open phase, Comi said, but only 21% of patients had confirmed disease progression during the five-year trial, making it difficult to extract a signal on disability progression "from the noise."

The conclusion, he said, was that there is a persistent benefit from early treatment versus delaying it for two years after a first event. "It's important not to lose time, not to delay in treating patients."

Carlo Pozzilli, MD, of La Sapienza University in Rome, said these results reinforce what has been learned from similar studies with other disease-modifying therapies. "This confirms what we already know about both Copaxone and early treatment" with other drugs, he said.

"All the studies in CIS patients make an argument for starting early."

Comi has received compensation from Teva Pharmaceuticals, the manufacturer of the study drug.